← Back to Search

Risankizumab for Psoriatic Arthritis (KEEPsAKE2 Trial)

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.

Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

KEEPsAKE2 Trial Summary

This trial will test the safety and effectiveness of a new drug, risankizumab, for treating psoriatic arthritis.

Who is the study for?

This trial is for adults with active psoriatic arthritis, having at least 5 tender and swollen joints, plaque psoriasis or nail changes. It's specifically for those who didn't respond well to or couldn't tolerate previous biologic therapies or conventional treatments.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of a drug called Risankizumab against a placebo in treating moderate to severe psoriatic arthritis. Participants are randomly assigned to receive either the drug or placebo.See study design

What are the potential side effects?

Possible side effects of Risankizumab may include allergic reactions, infections due to immune system suppression, injection site reactions, headaches, and fatigue. The exact side effects will be monitored throughout the trial.

KEEPsAKE2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have at least 5 tender and 5 swollen joints.

Select...

I have active plaque psoriasis with a plaque larger than 2 cm or nail changes.

KEEPsAKE2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rheumatoid Factor

Secondary outcome measures

Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24

Diabetes Insipidus

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

+7 more

KEEPsAKE2 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RisankizumabExperimental Treatment2 Interventions

Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Group II: PlaceboPlacebo Group2 Interventions

Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Isopropyl alcohol

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,600 Total Patients Enrolled

22 Trials studying Psoriatic Arthritis

108,461 Patients Enrolled for Psoriatic Arthritis

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,434 Total Patients Enrolled

6 Trials studying Psoriatic Arthritis

9,226 Patients Enrolled for Psoriatic Arthritis

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

101,113 Total Patients Enrolled

11 Trials studying Psoriatic Arthritis

13,626 Patients Enrolled for Psoriatic Arthritis

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03671148 — Phase 3

Psoriatic Arthritis Research Study Groups: Risankizumab, Placebo

Psoriatic Arthritis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03671148 — Phase 3

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03671148 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can eligible patients sign up for this research program?

"This study is not recruiting patients at this moment in time. The clinical trial was initially posted on 3/7/2019 and was last updated on 2/28/2022. However, there are 384 other trials actively searching for patients with psoriatic arthritis and 31 trials for risankizumab that are enrolling participants."

Answered by AI

Is this trial prominent in the United States?

"The trial is being conducted at Trinity Universal Research Association /ID# 208387 in Plano, Texas, West Tennessee Research Inst /ID# 166429 in Jackson, Tennessee, Clayton Medical Associates dba Saint Louis Rheumatology /ID# 166389 in Saint Louis, Missouri, and 79 other research centres."

Answered by AI

How is risankizumab most often employed?

"Risankizumab is an effective therapy for treating dental plaque, psoriasis, and skin disinfection."

Answered by AI

How many patients have signed up to participate in this experiment?

"Currently, this trial is inactive and not looking for any participants. The trial was initially posted on 3/7/2019 and was last edited on 2/28/2022. However, there are 384 other trials for psoriatic arthritis and 31 trials for risankizumab that are actively enrolling patients right now."

Answered by AI

Is this the first time that risankizumab has been used in a clinical setting?

"At the moment, there are 31 clinical trials underway that are studying risankizumab. Out of those 31 trials, 16 are in Phase 3. The majority of the trials for risankizumab are taking place in Gdansk, Pomorskie, but there are 3290 total locations running these sorts of studies."

Answered by AI

When will risankizumab be available to the general public?

"There is some data supporting efficacy and multiple rounds of data supporting safety, so we have estimated the safety of risankizumab to be a 3."

Answered by AI

What goal is this experiment trying to achieve?

"The primary outcome of this study is the percentage of participants achieving at least 20% improvement in American College of Rheumatology (ACR20) scores. Secondary outcomes include the percentage of participants with an ACR20 response at Week 16, defined as participants who meet the following 3 conditions for improvement from Baseline: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, patient global assessment of disease activity, patient assessment of pain, Health Assessment Questionnaire"

Answered by AI

Recent research and studies

Annals of the Rheumatic DiseasesJournal

Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-week Results from the Randomised, Double-blind, Phase 3 Keepsake 2 Trial

Östör, Andrew, Filip Van den Bosch, Kim Papp, Cecilia Asnal, Ricardo Blanco, Jacob Aelion, Gabriela Alperovich, et al.. 2021. “Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-week Results from the Randomised, Double-blind, Phase 3 Keepsake 2 Trial”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2021-221048.

Annals of the Rheumatic DiseasesJournal

Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-week Results from the Randomised, Double-blind, Phase 3 Keepsake 2 Trial

RMD OpenJournal

Improved Patient-reported Outcomes in Patients with Psoriatic Arthritis Treated with Risankizumab: Analysis of the Phase 3 Trial Keepsake 2

Ostor, Andrew J K, Ahmed M Soliman, Kim A Papp, Byron Padilla, Zailong Wang, Ann Eldred, Kurt de Vlam, and Alan Kivitz. 2022. “Improved Patient-reported Outcomes in Patients with Psoriatic Arthritis Treated with Risankizumab: Analysis of the Phase 3 Trial Keepsake 2”. RMD Open. BMJ. doi:10.1136/rmdopen-2022-002286.

clinicaltrials.govStudy

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)